SynthesisAdvances in therapy2026
Comparative Efficacy and Safety of Tislelizumab in Second-Line Esophageal Squamous Cell Carcinoma: Systematic Literature Review and Simulated Treatment Comparisons.
Synthesis in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03430843 (A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEsophageal squamous cell carcinoma (ESCC) accounts for approximately 90% of all esophageal cancer cases and is associated with poor prognosis. However, recent advancements have transformed the treatment landscape. Tislelizumab, a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, was developed to overcome resistance mechanisms by minimizing binding to FcγR on macrophages. The RATIONALE-302 clinical trial showed statistically significant survival benefits of tislelizumab over chemotherapy in second-line ESCC highlighting the necessity of evaluating comparative efficacy with existing treatments. This study aimed to identify trials evaluating anti-PD-1 therapies for second-line ESCC and indirectly estimate the relative efficacy of tislelizumab versus existing anti-PD-1 therapies.
methodsA systematic literature review (SLR) was originally conducted in 2021 then updated in 2022 and 2023. A feasibility assessment (FA) was undertaken to evaluate required assumptions for indirect treatment comparisons (ITCs) and determined that anchored simulated treatment comparisons (STCs) were the most appropriate methodology. Assessed outcomes included overall survival (OS), progression-free survival (PFS), and grade ≥ 3 treatment-related adverse events (TRAEs). Analyses were conducted in the hazard ratio scale for OS and PFS and in the odds ratio scale for TRAEs, whilst uncertainty was expressed in 95% confidence intervals.
resultsThe SLR identified 13 studies, six of which evaluated immunotherapies and were included in the FA. All studies were deemed similar and considered in the ITC, except for RAMONA, which differed substantially in study design, inclusion criteria, and patient characteristics. Indirect estimates obtained from the STCs were not statistically significant, except for the comparison of TRAEs with tislelizumab versus camrelizumab, where tislelizumab was more favorable.
conclusionsTislelizumab appears comparable to existing anti-PD-1 therapies (nivolumab, pembrolizumab, camrelizumab, and sintilimab) in OS, PFS, and TRAEs of grade ≥ 3 for patients receiving second-line treatment for ESCC with a potentially more favorable TRAE grade ≥ 3 profile than camrelizumab that requires confirmation.
trial registrationNCT03430843.
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